Background: Pain cognitions and illness perceptions have shown significant impact on outcomes in patients with longstanding low back pain (LBP), and therefore are often targeted in cognitive-based education programmes for LBP. The COPE (Cognitive Patient Education) project is a multidisciplinary trial taking place in primary care with the overall aim to estimate the effectiveness of a cognitive neurophysiology education programme, Explain Pain, provided by general practitioners (GP) and physiotherapists (PT). In such a trial it is important to use commonly used patient-reported outcomes (PROMs) such as the Roland Morris Disability Questionnaire (RMDQ) and the Euro QoL (EQ5D). Due to methodological critics towards the existing recommended PROMs it is important to include other types of PROMs, in particular measures of psychological aspects and individualised quality-of-life measures, in which the patients themselves define the items to be scored.
Objective: The main objective was to evaluate whether the Explain Pain programme provided by GPs and PTs in the primary care to patients with longstanding LBP was more effective than usual care in terms of improving disability and quality-of-life. Secondary aims were to assess the measurement properties of a measure of illness perceptions, the Brief Illness Perception Questionnaire (Brief IPQ), and the Patient Generated Index (PGI), a measure of individualised quality-of-life. Finally, we aimed to investigate the impact of psychological aspects on the 12-months outcomes.
Methods: Reliability and validity of the Brief IPQ and the PGI were assessed in 90 patients with LBP attending primary or secondary care in Norway. The pragmatic cluster-randomised controlled trial included 16 GPs and 20 PTs from primary care in South-East Norway, who were block randomly assigned to either provide Explain Pain in addition to usual treatment or only usual treatment. The clinicians recruited consecutive consulting patients with non-specific LBP of > 4 weeks but < 1 year duration, aged 20 to 55 years, to participate in the study. The Explain Pain programme was provided weekly up to 4 sessions, each session lasting 30 minutes. The control clinicians also had to provide 4 sessions in order to control for attention bias. The patients, outcome assessors, and study statistician were blinded to group allocation. Outcome were assessed after treatment (4 weeks) and at 12 months follow-up by the RMDQ (primary), pain, quality-of-life (PGI and EQ5D), and cost-effectiveness. Psychological measures were the Brief IPQ, the Pain Catastrophizing scale (PCS), and distress by the Hopkins Symptom Check List (HSCL25).
Results: The Brief IPQ and the PGI had little missing data and no floor or ceiling effects, and acceptable reliability and validity. In the trial, 6 GPs and 9 PTs in the intervention group and 6 GPs and 10 PTs in the control group provided data to the trial. A total of 216 patients reported baseline data, approxiately 81% responded at 4-weeks and 68% at the 12 months follow-up. Mixed model analyses showed no statistically significant difference between the intervention and control groups in any of the outcomes, except the Brief IPQ. Illness perceptions improved significantly among the patients in the intervention group compared to those in the control group at 4 weeks follow-up, but not after 12 months. All analyses also showed a statistically significant larger decrease in the outcomes among the PT patients than among the GP patients, but importantly, with no difference between the intervention and control groups. The level of illness perceptions and pain catastrophizing at baseline was significantly associated with the outcomes at 12 months, explaining 2.5 to 7.9% of the variation in the RMDQ and the EQ5D at 12 months.
Conclusion: The COPE trial showed no clinical or health economic benefit of adding the Explain Pain programme to usual treatment for patients with LBP. All patients showed a gradual and relatively large improvement throughout the follow-up period. The results were similar across the commonly used outcome measures of disability and quality-of-life and recently recommended outcome measures of individualized quality-of-life. The only exception was the measure of illness perceptions, which indicated an effect of the Explain Pain after the intervention at 4 weeks, but not 12 months. Illness perceptions and pain catastrophizing were also associated with 12-months outcomes. Potential weaknesses such as long recrution time and relatively large loss to follow-up warrant a careful interpretation of the results. A main strength is the use of other types of PROMs in addition to commonly used PROMs, and the thorough investigation of measurement properties of the included outcomes. The instruments can be recommended to Norwegian patients.Further studies are needed to establish whether cognitive interventions might be effective among patients with high risk of chronic LBP.
This is a multidisciplinary trial taking place in primary care clinical settings, aiming at improving knowledge and treatment of low back pain (LBP) patients by using a simple cognitive intervention which can be easily implemented in daily practices at fa mily doctors and physiotherapists clinics. In the cluster randomised controlled trial 20 general practitioners (GPs) and 20 physiotherapists (PTs) from different primary care clinics in South-East Norway have been randomised to an intervention and control group, respectively. Each practitioner is supposed to recruit 10 patients, aged 20 to 55 years, with non-specific LBP of more than 4 weeks but less than 1 year duration. Sample size is calculated to 300 patients, and current we have approximately 140 pat ients included. Practitioners in the intervention arm provide cognitive patient education in weekly sessions up to four times, each session lasting 30 minutes. Practitioners in the control arm provide treatment as usual, and make four appointments with th e patients, to control for attention bias. Patients, outcome assessors, and study statistician are blinded to group allocation.
The study concerns a patient group that is abundant with great expenses for the individual and the society, and is a direct co ntinuation of previous research at The Norwegian Back Pain Network. In the development of this study protocol, knowledge, methodological expertise and in particular, the broad collaborating network of clinicians and researchers established through the pre vious Norwegian Back Pain Network has been used. In addition, the researchers? international network has been used.
We estimate two more years of data collection and one year to finish analysis/publishing of this study. The project has received funding f rom the Medical Association to cover expenses to the included clinicians, but lack funding for positions to a 50% project coordinator and a 100% doctoral fellowship.